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Completed

NCT Number: NCT07736690

Perioperative Topical Nepafenac After Epiretinal Membrane Surgery

This prospective comparative study evaluates whether perioperative topical nepafenac improves early anatomical and functional recovery after pars plana vitrectomy with epiretinal membrane and internal limiting membrane peeling. The study compares postoperative visual acuity, central macular thickness, and other clinical outcomes between patients treated with perioperative nepafenac and those receiving standard postoperative care.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Ankara Bilkent City Hospital

Ankara, 06800, Turkey (Türkiye)

About this study

Epiretinal membrane (ERM) surgery generally results in favorable anatomical outcomes; however, postoperative retinal inflammation may delay visual and structural recovery. Nepafenac is a topical nonsteroidal anti-inflammatory drug with excellent intraocular penetration and may reduce postoperative inflammation.

This prospective comparative study investigates the effect of perioperative topical nepafenac on early postoperative recovery following pars plana vitrectomy with epiretinal membrane and internal limiting membrane peeling.

Participants were assigned to receive either perioperative topical nepafenac or standard postoperative treatment. The primary objective is to compare anatomical recovery, measured by optical coherence tomography, and functional recovery, assessed by best-corrected visual acuity. Secondary outcomes include changes in central macular thickness and postoperative complications.

The findings may help determine whether perioperative topical nepafenac provides additional benefit in improving early postoperative outcomes after epiretinal membrane surgery.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

-

  • Adults aged 18 years or older.
  • Diagnosis of idiopathic epiretinal membrane requiring pars plana vitrectomy.
  • Best-corrected visual acuity impairment and/or metamorphopsia attributed to epiretinal membrane.
  • Ability to provide written informed consent.
  • Willingness to complete the scheduled follow-up examinations for 6 months.

Exclusion criteria

  • - Previous vitreoretinal surgery in the study eye.
  • Other retinal diseases that could affect visual or anatomical outcomes (e.g., diabetic retinopathy, retinal vein occlusion, age-related macular degeneration).
  • Significant ocular trauma.
  • Active ocular inflammation or infection.
  • Advanced glaucoma or optic neuropathy affecting visual function.
  • Media opacity preventing adequate retinal imaging.

Treatment and study plan

Nepafenac 0.1% Ophthalmic Suspension

Drug

Topical nepafenac 0.1% administered three times daily beginning one week before surgery and continued for four weeks after surgery, in addition to standard postoperative treatment.

Pars Plana Vitrectomy With Epiretinal Membrane and Internal Limiting Membrane Peeling

Procedure

Standard pars plana vitrectomy with epiretinal membrane and internal limiting membrane peeling performed for epiretinal membrane.

Primary outcomes

  1. Change in Best-Corrected Visual Acuity (BCVA)

    Time frame: 6 months after surgery

    To compare the change in best-corrected visual acuity (logMAR) between the perioperative nepafenac group and the control group following epiretinal membrane surgery.

Secondary outcomes

  1. Change in Central Macular Thickness (CMT)

    Time frame: 6 months after surgery

    To compare postoperative central macular thickness measured by spectral-domain optical coherence tomography between the two groups.

  2. Integrity of the Ellipsoid Zone

    Time frame: 6 months after surgery

    To evaluate postoperative restoration of the ellipsoid zone using optical coherence tomography.

  3. Postoperative Complications

    Time frame: 6 months after surgery

    To compare the incidence of postoperative complications between the two treatment groups.

Sponsors and collaborators

Lead sponsor

Ankara Yildirim Beyazıt University

Other

Registry information

Official study title

Perioperative Topical Nepafenac Enhances Early Anatomical and Functional Recovery After Epiretinal Membrane Surgery: A Prospective Comparative Study

Acronym: NEPERM

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jul 30, 2026
Registry last updated
Jul 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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